Hybrid adjunct materials for use in surgical stapling

ABSTRACT

Implantable materials for use with end effectors like surgical stapling devices, and methods associated with the operation of such end effectors, are provided herein. In one exemplary embodiment, a staple cartridge assembly includes a cartridge body and a hybrid adjunct material. The cartridge body has a plurality of staple cavities configured to seat staples therein. The hybrid adjunct material is releasably retained on the cartridge body and configured to be delivered to tissue by deployment of the staples in the cartridge body. The material includes a biologic tissue membrane, a synthetic substrate layer, and at least one compressible elastic member configured to compress when a compressive force is applied thereto, and to provide a spring back force when the compressive force is removed. Other implants, devices, and methods for surgical stapling are also provided.

FIELD

The present invention relates to surgical instruments, and in particularto methods, devices, and components thereof for cutting and staplingtissue.

BACKGROUND

Surgical staplers are used in surgical procedures to close openings intissue, blood vessels, ducts, shunts, or other objects or body partsinvolved in the particular procedure. The openings can be naturallyoccurring, such as passageways in blood vessels or an internal organlike the stomach, or they can be formed by the surgeon during a surgicalprocedure, such as by puncturing tissue or blood vessels to form abypass or an anastomosis, or by cutting tissue during a staplingprocedure.

Most staplers have a handle with an elongate shaft having a pair ofmovable opposed jaws formed on an end thereof for holding and formingstaples therebetween. The staples are typically contained in a staplecartridge, which can house multiple rows of staples and is oftendisposed in one of the two jaws for ejection of the staples to thesurgical site. In use, the jaws are positioned so that the object to bestapled is disposed between the jaws, and staples are ejected and formedwhen the jaws are closed and the device is actuated. Some staplersinclude a knife configured to travel between rows of staples in thestaple cartridge to longitudinally cut and/or open the stapled tissuebetween the stapled rows.

While surgical staplers have improved over the years, a number ofproblems still present themselves. One common problem is that leaks canoccur due to the staple forming holes when penetrating the tissue orother object in which it is disposed. Blood, air, gastrointestinalfluids, and other fluids can seep through the openings formed by thestaples, even after the staple is fully formed. The tissue being treatedcan also become inflamed due to the trauma that results from stapling.Still further, staples, as well as other objects and materials that canbe implanted in conjunction with procedures like stapling, generallylack some characteristics of the tissue in which they are implanted. Forexample, staples and other objects and materials can lack the naturalflexibility of the tissue in which they are implanted. A person skilledin the art will recognize that it is often desirable for tissue tomaintain as much of its natural characteristics as possible afterstaples are disposed therein.

In some instances, biologic materials have been used in conjunction withtissue stapling. However, the use of biologic materials has presented anumber of problems. For example, biologics can lack desired mechanicalproperties such as springiness or elasticity (i.e., they do not recover,or spring back, after being compressed). Biologics can lack the abilityto sufficiently reinforce tissue at a surgical site. Further, it cansometimes be difficult or even impossible to manufacture biologicmaterials to an exact required shape and/or thickness (e.g., tocompensate for variations in tissue thickness, which might only be knownat the time of surgery).

Accordingly, there remains a need for improved devices and methods forstapling tissue, blood vessels, ducts, shunts, or other objects or bodyparts such that leaking and inflammation is minimized whilesubstantially maintaining the natural characteristics of the treatmentregion.

SUMMARY

In various aspects and embodiments, the invention provides implantablematerials for use with end effectors like surgical stapling devices, andmethods associated with the operation of such end effectors.

In one aspect, the invention provides a staple cartridge assembly thatincludes a cartridge body and a hybrid adjunct material. The cartridgebody has a plurality of staple cavities configured to seat staplestherein. The hybrid adjunct material is releasably retained on thecartridge body and configured to be delivered to tissue by deployment ofthe staples in the cartridge body. The material includes a biologictissue membrane, a synthetic substrate layer, and at least onecompressible elastic member configured to compress when a compressiveforce is applied thereto, and to provide a spring back force when thecompressive force is removed.

In another aspect, the invention provides a hybrid adjunct material thatincludes a biologic tissue membrane, a synthetic substrate layer, and atleast one compressible elastic member configured to compress when acompressive force is applied thereto, and to provide a spring back forcewhen the compressive force is removed. Furthermore, the material isconfigured to be releasably retained on a surgical stapler cartridgebody for delivery to tissue upon deployment of staples from thecartridge body.

In another aspect, the invention provides a method for staplingbiological tissue. The method includes engaging tissue with a surgicalstapler cartridge body at a surgical site, the cartridge body having ahybrid adjunct material releasably retained thereon, the materialcomprising a biologic tissue membrane, a synthetic substrate layer, andat least one compressible elastic member configured to compress when acompressive force is applied thereto, and to provide a spring back forcewhen the compressive force is removed. The method also includesactuating the surgical stapler to eject staples from the cartridge bodyinto the biological tissue, the staples extending through the materialto maintain the material at the surgical site.

In various embodiments, the invention contemplates all functioningcombinations of the aspects above with any one or more of the featuresbelow (in addition to the other aspects and embodiments describedherein).

In various embodiments, the material is bioimplantable andbioabsorbable.

In various embodiments, the elastic member is disposed between thebiologic tissue membrane and the synthetic substrate layer.Alternatively, the elastic member can be disposed in one or both of thebiologic tissue membrane and the synthetic substrate layer.

In various embodiments, the assembly includes at least one retentionmember configured to couple the material to the cartridge body. The atleast one retention member can be coupled to an outer edge of thecartridge body and an outer edge of at least one of the biologic tissuemembrane and the synthetic substrate layer. The at least one retentionmember can include a suture.

In various embodiments, the membrane includes a biological matrix.

In various embodiments, the compressible elastic member includes asynthetic bioabsorbable material. The synthetic bioabsorbable materialcan be a nylon, polypropylene, polydioxanon, a polyglycerol sebacate(PGS), PGA (polyglycolic acid), PCL (polycaprolactone), PLA or PLLA(polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25),polyglactin910, poly glyconate, PGA/TMC (polyglycolide-trimethylene),polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP), poly(vinylalcohol) (PVA), or a combination thereof.

In various embodiments, the compressible elastic member can include atleast one member extending across at least one dimension of the materialin a sinusoidal pattern. The compressible elastic member can furtherinclude a plurality of sinusoidal members extending across at least oneof a length dimension and a width dimension of the material.

In various embodiments, the compressible elastic member includes one ormore surface features configured to fix the membrane to the elasticmember. The one or more surface features can be selected from the groupconsisting of ball shaped end caps, shelves, barbs, and combinationsthereof.

In various embodiments, the compressible elastic member includes one ormore of a spheroid, ovoid, hemispherical, dome, jack-like, orthree-dimensional radial form.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one exemplary embodiment of a surgicalinstrument having an attachment portion attached to a distal endthereof;

FIG. 2 is a perspective view of the surgical instrument of FIG. 1 withthe attachment portion detached from a shaft of the instrument;

FIG. 3 is a perspective view of the attachment portion of FIG. 2including at least one piece of adjunct material;

FIG. 4 is an exploded perspective view of the end effector of FIG. 3with the adjunct material removed;

FIG. 5 is a detailed perspective view of a distal end of a staplecartridge for use with the end effector of FIG. 4;

FIG. 6 is a side cross-sectional view taken along the section lineindicated in FIG. 5;

FIG. 7 is a bottom perspective view of the staple cartridge of FIG. 5;

FIG. 8 is a detailed perspective view of an actuation sled, pushers, andfasteners of the surgical instrument of FIG. 4;

FIG. 9 is a perspective view of another exemplary embodiment of anattachment portion for use a surgical instrument;

FIG. 10 is an exploded perspective view of an end effector of theattachment portion of FIG. 9;

FIG. 11 is an exploded view of a drive assembly for use with the endeffector of FIG. 4;

FIG. 12 is a perspective view of a lower jaw of the end effector of FIG.3;

FIG. 13 is a perspective view of an upper jaw of the end effector ofFIG. 3, the upper jaw having an adjunct material associated therewith;

FIG. 14 is a perspective view of portions of the end effector of FIG. 2including a retention member configured to releasably retain an adjunctmaterial;

FIG. 15 is a perspective view of a lower jaw of the end effector of FIG.10;

FIG. 16 is a perspective view of an exemplary staple cartridge having ahybrid adjunct material in accordance with the present invention.

FIGS. 17-19 are perspective views illustrating exemplary attachments ofbiological tissue reinforcement membranes to cartridge bodies, andexemplary compressible elastic members.

FIG. 20A-20C is an exploded view of variations of the compressibleelastic members illustrated in FIGS. 17-19.

FIGS. 21-23 are cross sectional views illustrating the operation of theexemplary staple cartridge of FIG. 16.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. Further, in the present disclosure,like-numbered components of the various embodiments generally havesimilar features when those components are of a similar nature and/orserve a similar purpose.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment,” or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment,” or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, thoseskilled in the art will appreciate that the various methods and devicesdisclosed herein can be used in numerous surgical procedures andapplications. Those skilled in the art will further appreciate that thevarious instruments disclosed herein can be inserted into a body in anyway, such as through a natural orifice, through an incision or puncturehole formed in tissue, or through an access device, such as a trocarcannula. For example, the working portions or end effector portions ofthe instruments can be inserted directly into a patient's body or can beinserted through an access device that has a working channel throughwhich the end effector and elongated shaft of a surgical instrument canbe advanced.

It can be desirable to use one or more biologic materials and/orsynthetic materials, collectively referred to herein as “adjunctmaterials,” in conjunction with surgical instruments to help improvesurgical procedures. A person skilled in the art may refer to thesetypes of materials as buttress materials as well as adjunct materials.While a variety of different end effectors can benefit from the use ofadjunct materials, in some exemplary embodiments the end effector can bea surgical stapler. When used in conjunction with a surgical stapler,the adjunct material(s) can be disposed between and/or on jaws of thestapler, incorporated into a staple cartridge disposed in the jaws, orotherwise placed in proximity to the staples. When staples are deployed,the adjunct material(s) can remain at the treatment site with thestaples, in turn providing a number of benefits. In some instances, thematerial(s) can be used to help seal holes formed by staples as they areimplanted into tissue, blood vessels, and various other objects or bodyparts. Further, the materials can be used to provide tissuereinforcement at the treatment site. Still further, the materials canhelp reduce inflammation, promote cell growth, and otherwise improvehealing.

Some configurations of adjunct materials include both synthetic andbiologic materials. The combination of both types of materials canresult in the formation of a hybrid adjunct material. Hybrid adjunctmaterials, when properly designed and/or selected, can combinebeneficial features of synthetic material(s) and beneficial features ofbiologic material(s) in a single hybrid adjunct material. Thus, while anotherwise desirable biologic material may lack an also desirablemechanical (or other) property, combining the biologic material with asynthetic material providing that mechanical (or other) property canprovide a hybrid adjunct material having both desirable properties. Forexample, a hybrid adjunct material can be designed to combine benefitsof biologic material (such as improved healing and tissue growth at asurgical site) with desirable mechanical properties of syntheticmaterial (such as springiness or elasticity in the resulting hybridadjunct material).

Surgical Stapling Instrument

While a variety of surgical instruments can be used in conjunction withthe adjunct materials disclosed herein, FIGS. 1 and 2 illustrate one,non-limiting exemplary embodiment of a surgical stapler 10 suitable foruse with one or more adjunct materials. As shown the instrument 10includes a handle assembly 12, a shaft 14 extending distally from adistal end 12 d of the handle assembly 12, and an attachment portion 16removably coupled to a distal end 14 d of the shaft 14. Because theillustrated embodiment is a surgical stapler, a distal end 16 d of theattachment portion 16 includes an end effector 50 having jaws 52, 54,although other types of end effectors can be used with the shaft 14,handle assembly 12, and components associated with the same. As shown,the surgical stapler includes opposed first and second jaws 52, 54 withthe first, lower jaw 52 including an elongate channel 56 (FIG. 4)configured to support a staple cartridge 100, and the second, upper jaw54 having an inner surface 58 (FIGS. 3, 4, and 6) that faces the lowerjaw 52 and that is configured to operate as an anvil to help deploystaples of a staple cartridge. The jaws 52, 54 are configured to moverelative to one another to clamp tissue or other objects disposedtherebetween, and an axial drive assembly 80 (FIG. 11) can be configuredto pass through at least a portion of the end effector 50 to eject thestaples into the clamped tissue. In various embodiments a knife blade 81can be associated with the axial drive assembly 80 to cut tissue duringthe stapling procedure.

Operation of the end effector 50 and drive assembly 80 can begin withinput from a clinician at the handle assembly 12. The handle assembly 12can have many different configurations designed to manipulate andoperate the end effector associated therewith. In the illustratedembodiment, the handle assembly 12 has a pistol-grip type housing 18with a variety of mechanical components disposed therein to operatevarious features of the instrument. For example, the handle assembly 12can include mechanical components as part of a firing system actuated bya trigger 20. The trigger 20 can be biased to an open position withrespect to a stationary handle 22, for instance by a torsion spring, andmovement of the trigger 20 toward the stationary handle 22 can actuatethe firing system to cause the axial drive assembly 80 to pass throughat least a portion of the end effector 50 and eject staples from astaple cartridge disposed therein. A person skilled in the art willrecognize various configurations of components for a firing system,mechanical or otherwise, that can be used to eject staples and/or cuttissue, and thus a detailed explanation of the same is unnecessary.

Other non-limiting examples of features that can be incorporated intothe handle assembly 22 that affect manipulation and operation of an endeffector associated therewith include a rotatable knob 24, anarticulation lever 26, and retraction knobs 28. As shown, the rotatableknob 24 can be mounted on a forward end of a barrel portion 30 of thehandle assembly 12 to facilitate rotation of the shaft 14 (or theattachment portion 16) with respect to the handle assembly 12 around alongitudinal axis L of the shaft 14. The actuation lever 26 can also bemounted on a forward end of the barrel portion 30, approximatelyadjacent to the rotatable knob 24. The lever 26 can be manipulated fromside-to-side along a surface of the barrel portion 30 to facilitatereciprocal articulation of the end effector 50. One or more retractionknobs 28 can be movably positioned along the barrel portion 30 to returnthe drive assembly 80 to a retracted position, for example after thefiring system has completed a firing stroke. As shown, the retractionknobs 28 move proximally toward a back end of the barrel portion 30 toretract components of the firing system, including the drive assembly80.

Still other non-limiting examples of features that can be incorporatedinto the handle assembly 22 that affect manipulation and operation of anend effector associated therewith can include a firing lockout assembly,an anti-reverse clutch mechanism, and an emergency return button. Afiring lockout assembly can be configured to prevent the firing systemfrom being actuated at an undesirable time, such as when an end effectoris not fully coupled to the instrument. An anti-reverse clutch mechanismcan be configured to prevent components of the firing system from movingbackwards when such backwards movement is undesirable, such as when thefiring stroke has only been partially completed but temporarily stopped.An emergency return button can be configured to permit components of afiring system to be retracted before a firing stroke is completed, forinstance in a case where completing the firing stroke may cause tissueto be undesirably cut. Although features such as a firing lockoutassembly, an anti-reverse clutch mechanism, and an emergency returnbutton are not explicitly illustrated in the instrument 10, a personskilled in the art will recognize a variety of configurations for eachfeature that can be incorporated into a handle assembly and/or otherportions of a surgical stapler without departing from the spirit of thepresent disclosure. Additionally, some exemplary embodiments of featuresthat can be incorporated into the handle assembly 12 are provided for inpatents and patent applications incorporated by reference elsewhere inthe present application.

The shaft 14 can be removably coupled to the distal end 12 d of thehandle assembly 12 at a proximal end 14 p of the shaft 14, and a distalend 14 d of the shaft 14 can be configured to receive the attachmentportion 16. As shown, the shaft 14 is generally cylindrical andelongate, although any number of shapes and configurations can be usedfor the shaft, depending, at least in part, on the configurations of theother instrument components with which it is used and the type ofprocedure in which the instrument is used. For example, in someembodiments, a distal end of one shaft can have a particularconfiguration for receiving certain types of end effectors, while adistal end of another shaft can have a different configuration forreceiving certain other types of end effectors. Components of the firingsystem, such as a control rod 32 (FIG. 2), can be disposed in the shaft14 so that the components can reach the end effector 50 and driveassembly 80 to provide actuation of the same. For example, when thetrigger 20 operates the firing system, the control rod 32 can beadvanced distally through at least a portion of the shaft 14 to causethe jaws 52, 54 to collapse towards each other and/or to drive the driveassembly 80 distally through at least a portion of the end effector 50.

The shaft 14 can also include one or more sensors (not shown) andrelated components, such as electronic components to help operate anduse the sensors (not shown). The sensors and related components can beconfigured to communicate to a clinician the type of end effectorassociated with the distal end 14 d of the shaft 14, among otherparameters. Likewise, the handle assembly 12 can include one or moresensors and related components configured to communicate to a clinicianthe type of end effector and/or shaft associated with the distal end 12d of the handle assembly 12. Accordingly, because a variety of shaftscan be interchangeably coupled with the handle assembly 12 and a varietyof end effectors having different configurations can be interchangeablycoupled with various shafts, the sensors can help a clinician know whichshaft and end effector are being used. Additionally, the informationfrom the sensors can help a monitoring or control system associated withthe instrument know which operation and measurement parameters arerelevant to a clinician based on the type of shaft and end effectorcoupled to the handle assembly. For example, when the end effector is astapler, information about the number of times the drive assembly 80 isfired may be relevant, and when the end effector is another type of endeffector, such as a cutting device, the distance the cutting portiontraveled may be relevant. The system can convey the appropriateinformation to the clinician based on the end effector that is sensed.

A person skilled in the art will recognize that various configurationsof monitoring and control systems can be used in conjunction with thesurgical instruments provided herein. For example, sensors associatedwith any of the end effector 50, the attachment portion 16, the shaft14, and the handle assembly 12 can be configured to monitor other systemparameters, and a monitoring or control system can communicate to aclinician the relevant other parameters based on the type of shaft orattachment portion associated with the handle assembly. Further detailsabout sensors and related components, as well as monitoring and controlsystems, can be found in patents and patent applications incorporated byreference elsewhere in the present application.

As shown in FIG. 3, the attachment portion 16 can include a proximalhousing portion 34 at a proximal end 16 p thereof and an end effector ortool 50 at a distal end 16 d thereof. In the illustrated embodiment, theproximal housing portion 34 includes on a proximal end 34 p thereofengagement nubs 36 for releasably engaging the shaft 14. The nubs 36form a bayonet type coupling with the distal end 14 d of the shaft 14.Besides nubs 36, any number of other complementary mating features canbe used to allow the attachment portion 16 to be removably coupled tothe shaft 14.

A distal end 34 d of the proximal housing portion 34 can include amounting assembly 40 pivotally secured thereto. As shown in FIG. 4, themounting assembly 40 can be configured to receive a proximal end 50 p ofthe end effector 50 such that pivotal movement of the mounting assembly40 about an axis perpendicular to the longitudinal axis of the housingportion 34 effects articulation of the end effector 50 about a pivotmember or pin 42. This pivotal movement can be controlled by theactuation lever 26 of the handle assembly 28, with components beingdisposed between the lever 26 and the mounting assembly 40 to allow formovement of the lever 26 to articulate the mounting assembly 40, andthereby the end effector 50. Similar to the firing system of theinstrument 10, a person skilled in the art will recognize variousconfigurations of components for effecting articulation, mechanical orotherwise, and thus a detailed explanation of the same is unnecessary.Some exemplary embodiments of components for effecting articulation thatare suitable for use with the disclosures herein are provided for inpatents and patent applications incorporated by reference elsewhere inthe present application.

The end effector 50 of the illustrated embodiment is a surgical staplingtool having a first, lower jaw 52 that serves as a cartridge assembly orcarrier and an opposed second, upper jaw 54 that serves as an anvil. Asshown in FIG. 6, an inner surface 58 of the second jaw 54, sometimesreferred to as an anvil portion, can include a plurality of stapledeforming cavities 60 and a cover plate 62 secured to a top surface 59of the jaw 54 to define a cavity 64 therebetween. The cover plate 62 canhelp to prevent pinching of tissue during clamping and firing of thesurgical stapler. The cavity 64 can be dimensioned to receive a distalend 80 d of the axial drive assembly 80. A longitudinal slot 66 canextend through the anvil portion 58 to facilitate passage of a retentionflange 82 of the axial drive assembly 80 into the anvil cavity 64. Acamming surface 57 formed on the anvil portion 58 can be positioned toengage the axial drive assembly 80 to facilitate clamping of tissue 99.A pair of pivot members 53 formed on the anvil portion 54 can bepositioned within slots 51 formed in the carrier 52 to guide the anvilportion between the open and clamped positions. A pair of stabilizingmembers can engage a respective shoulder 55 formed on the carrier 52 toprevent the anvil portion 54 from sliding axially relative to the staplecartridge 100 as the camming surface 57 is deformed. In otherembodiments, the carrier 52 and staple cartridge 100 can be pivotedbetween open and clamped positions while the anvil portion 54 remainssubstantially stationary.

The elongated support channel 56 of the first jaw 52 can be dimensionedand configured to receive a staple cartridge 100, as shown in FIGS. 4,5, and 7. Corresponding tabs 102 and slots 68 formed along the staplecartridge 100 and the elongated support channel 56, respectively,function to retain the staple cartridge 100 within the support channel56. A pair of support struts 103 formed on the staple cartridge 100 canbe positioned to rest on sidewalls of the carrier 52 to furtherstabilize the staple cartridge 100 within the support channel 56. Thestaple cartridge 100 can also include retention slots 105 for receivinga plurality of fasteners 106 and pushers 108. A plurality of spacedapart longitudinal slots 107 can extend through the staple cartridge 100to accommodate upstanding cam wedges 70 of an actuation sled 72 of afiring system (FIGS. 4 and 8). A central longitudinal slot 109 canextend along the length of the staple cartridge 100 to facilitatepassage of a knife blade 81 associated with the axial drive assembly 80.During operation of the surgical stapler, the actuation sled 72translates through longitudinal slots 107 of the staple cartridge 100 toadvance cam wedges 70 into sequential contact with pushers 108, therebycausing the pushers 108 to translate vertically within the retentionslots 105 and urge the fasteners 106 from the slots 105 into the stapledeforming cavities 60 of the anvil portion 54.

An alternative embodiment of an attachment portion 16′ is shown in FIGS.9 and 10. The attachment portion 16′ can include a proximal housingportion 34′ at a proximal end 16 p′ thereof and an end effector or tool50′ at a distal end 16 d′ thereof. Nubs 36′ can be provided to removablycouple the attachment portion 16′ to a shaft of a surgical instrument,and a mounting assembly 40′ can be provided to removably and/orpivotally couple an end effector or tool 50′ to the proximal housingportion 34′. The end effector 50′ can include a first, lower jaw 52′that serves as a cartridge assembly, and a second, upper jaw 54′ thatserves as an anvil portion. The first jaw 52′ can have many of the samefeatures as the first jaw 52 of FIGS. 3, 4, and 6, and thus can includean elongated support channel 56′ that is dimensioned and configured toreceive a staple cartridge 100′, and slots 68′ configured to correspondwith tabs 102′ of the staple cartridge 100′ to retain the cartridge 100′within the channel 56′. Likewise, the cartridge 100′ can include supportstruts 103′ to rest on sidewalls of the jaw 52′, retention slots 105′for receiving a plurality of fasteners 106′ and pushers 108′, aplurality of spaced apart longitudinal slots 107′ to accommodateupstanding cam wedges 70′ of an actuation sled 72′ of a firing system,and a central longitudinal slot 109′ to facilitate passage of a knifeblade 81′ associated with an axial drive assembly 80′.

Similar to the second jaw 54 of FIGS. 3, 4, and 6, the second jaw 54′can include a cover plate 62′ secured to a top surface of the jaws todefine a cavity therebetween. An anvil plate 58′ can serve as the innersurface of the jaw 54′, and can include a longitudinal slot 66′ forreceiving a distal end of the axial drive assembly 80′, and a pluralityof staple deforming pockets or cavities (not shown) to form staplesejected from the cartridge 100′. In this embodiment, however, the lowerjaw 52′ containing the cartridge 100′ is configured to pivot toward theupper jaw 54′ while the upper jaw 54′ remains substantially stationaryupon actuation by a handle assembly and related components.

The end effector and staple cartridge disposed therein is configured toreceive an axial drive assembly. One non-limiting exemplary embodimentof the axial drive assembly 80 is illustrated in FIG. 11. As shown, adistal end of a drive beam 84 can be defined by a vertical support strut86 that supports the knife blade 81, and an abutment surface 88configured to engage the central portion of the actuation sled 72 duringa stapling procedure. Bottom surface 85 at the base of the abutmentsurface 88 can be configured to receive a support member 87 slidablypositioned along the bottom of the staple cartridge 100 (FIGS. 4 and 6).The knife blade 81 can be positioned to translate slightly behind theactuation sled 72 through the central longitudinal slot 109 in thestaple cartridge 100 to form an incision between rows of stapled bodytissue. The retention flange 82 can project distally from the verticalstrut 86 and can support a cylindrical cam roller 89 at its distal end.The cam roller 89 can be dimensioned and configured to engage thecamming surface 57 on the anvil portion 58 to clamp the anvil portion 58against body tissue. A person skilled in the art will recognize that adrive assembly for use in conjunction with surgical staplers or othersurgical instruments can have many other configurations than the oneillustrated in FIG. 11, some of which are described in patents andpatent applications incorporated by reference elsewhere in the presentapplication. By way of non-limiting example, the drive assembly 80 caninclude a single drive beam, or any other number of drive beams, and thedistal end of the drive beam(s) can have any number of shapes that areconfigured for use in the end effector through which the drive assemblyis configured to travel.

In use, the surgical stapler can be disposed in a cannula or port anddisposed at a surgical site. A tissue to be cut and stapled can beplaced between the jaws 52, 54 of the surgical stapler 10. Features ofthe stapler 10, such as the rotating knob 24 and the actuation lever 26,can be maneuvered as desired by the clinician to achieve a desiredlocation of the jaws 52, 54 at the surgical site and the tissue withrespect to the jaws 52, 54. After appropriate positioning has beenachieved, the trigger 20 can be pulled toward the stationary handle 22to actuate the firing system. The trigger 20 can cause components of thefiring system to operate such that the control rod 32 advances distallythrough at least a portion of the shaft 14 to cause at least one of thejaws 52, 54 to collapse towards the other to clamp the tissue disposedtherebetween and/or to drive the drive assembly 80 distally through atleast a portion of the end effector 50.

In some embodiments, a first firing of the trigger 20 can cause the jaws52, 54 to clamp the tissue, while subsequent firings of the trigger 20can cause the drive assembly 80 to be advanced distally through at leasta portion of the end effector 50. A single, subsequent firing can fullyadvance the drive assembly 80 through the staple cartridge 100 to ejectthe staples in the row, or alternatively, the components in the handleassembly 12 can be configured such that multiple, subsequent firings arerequired to fully advance the drive assembly 80 through the staplecartridge 100 to eject the staples in the row. Any number of subsequentfirings can be required, but in some exemplary embodiments anywhere fromtwo to five firings can fully advance the drive assembly 80 through thestaple cartridge 100. In embodiments in which the drive assembly 80includes the knife 81 to cut the tissue being stapled, the knife 81 cutstissue as the drive assembly advances distally through the end effector50, and thus the staple cartridge 100 disposed therein. In otherexemplary embodiments, a motor disposed within the handle assembly 12and associated with a firing trigger can actuate the drive assembly 80automatically in response to activation of the firing trigger.

After the drive assembly 80 has been advanced distally through thestaple cartridge 100, the retraction knobs 28 can be advanced proximallyto retract the drive assembly 80 back towards its initial position. Insome configurations, the retraction knobs 28 can be used to retract thedrive assembly 80 prior to fully advancing the assembly 80 through thecartridge 100. In other embodiments retraction of the drive assembly 80can be automated to occur after a predetermined action. For example,once the drive assembly 80 has distally advanced to its desiredlocation, the subsequent return of the trigger 80 back to a biased openposition can cause the drive assembly 80 to automatically retract. Amotor and associated components, rather than retraction knobs 28 andassociated components, can be used to retract the drive assembly 80.Further, as discussed above, other features, such as a firing lockoutmechanism, an anti-reverse clutch mechanism, and an emergency returnbutton, can be relied upon during operation of the surgical stapler 10,as would be understood by those skilled in the art.

The illustrated embodiment of a surgical stapling instrument 10 providesone of many different configurations, and associated methods of use,that can be used in conjunction with the disclosures provided herein.Additional exemplary embodiments of surgical staplers, componentsthereof, and their related methods of use, which can be used inaccordance with the present disclosure include those devices,components, and methods provided for in U.S. Patent ApplicationPublication No. 2012/0083835 and U.S. Patent Application Publication No.2013/0161374, each of which is incorporated by reference herein in itsentirety.

Implantable Materials

Regardless of the configuration of the surgical instrument, the presentdisclosure provides for the use of implantable materials, e.g., biologicmaterials and/or synthetic materials, collectively “adjunct materials,”in conjunction with instrument operations. As shown in FIGS. 12 and 13,the end effector 50 can include at least one piece of adjunct material200, 200′ positioned intermediate the first and second jaw members 52,54 and it can be releasably retained to one of the support channel 56and/or the anvil portion 58. In the illustrated embodiment, thereleasable retention is provided by retention members 202, 202′, whichare described in further detail below. In at least one embodiment, asurface on the adjunct material 200, 200′ can be configured to contacttissue as the tissue is clamped between the first and second jaw members52, 54. In such an embodiment, the adjunct material can be used todistribute the compressive clamping force over the tissue, remove excessfluid from the tissue, and/or improve the purchase of the staples. Invarious embodiments, one or more pieces of adjunct material can bepositioned within the end effector 50. In at least one embodiment, onepiece of adjunct material 200 can be attached to the staple cartridge100 (FIG. 12) and one piece of adjunct material 200′ can be attached tothe anvil portion 58 (FIG. 13). In at least one other embodiment, twopieces of adjunct material 200 can be positioned on the support channel56 and one piece of adjunct material 200′ can be positioned on the anvilportion 58, for example. Any suitable number of adjunct materials can besituated within the end effector 50.

Adjunct material used in conjunction with the disclosures provided forherein can have any number of configurations and properties. Generally,they can be formed from of a bioabsorbable material, a biofragmentablematerial, and/or a material otherwise capable of being broken down, forexample, such that the adjunct material can be absorbed, fragmented,and/or broken down during the healing process. In at least oneembodiment, the adjunct material can include a therapeutic drug that canbe configured to be released over time to aid the tissue in healing, forexample. In further various embodiments, the adjunct materials caninclude a non-absorbable and/or a material not capable of being brokendown, for example. Similarly, the connection or retention members can beat least partially formed from at least one of a bioabsorbable material,a biofragmentable material, and a material capable of being broken downsuch that the connection or retention members can be absorbed,fragmented, and/or broken down within the body. In various embodiments,the connection or retention members can include a therapeutic drug thatcan be configured to be released over time to aid the tissue in healing,for example. In further various embodiments, the connection or retentionmembers can include a non-absorbable and/or a material not capable ofbeing broken down, for example, such as a plastic.

More particularly, some exemplary, non-limiting examples of syntheticmaterials that can be used in conjunction with the disclosures providedfor herein include biodegradable synthetic absorbable polymer such as apolydioxanon film sold under the trademark PDS® or with a Polyglycerolsebacate (PGS) film or other biodegradable films formed from PGA(Polyglycolic acid, marketed under the trade mark Vicryl), PCL(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.),Polyglactin910, Poly glyconate, PGA/TMC (polyglycolide-trimethylenecarbonate sold under the trademark Biosyn), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), or a blend ofcopolymerization of the PGA, PCL, PLA, PDS monomers. In use, thesynthetic material can be broken down by exposure to water such that thewater attacks the linkage of a polymer of the synthetic material. As aresult, the mechanical strength can become diminished, and a constructof the material can be broken down into a mushy or fractured scaffold.As further breakdown occurs such that the material breaks intocarbohydrates and acid constituents, a patient's body can metabolize andexpel the broken down materials.

Some exemplary, non-limiting examples of biologic derived materials thatcan be used in conjunction with the disclosures provided for hereininclude platelet poor plasma (PPP), platelet rich plasma (PRP), starch,chitosan, alginate, fibrin, thrombin, polysaccharide, cellulose,collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalinadhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid),agarose, polyetheretherketones, amylose, hyaluronan, hyaluronic acid,whey protein, cellulose gum, starch, gelatin, silk, or other materialsuitable to be mixed with biological material and introduced to a woundor defect site, including combinations of materials, or any materialapparent to those skilled in the art in view of the disclosures providedfor herein. Biologic materials can be derived from a number of sources,including from the patient in which the biologic material is to beimplanted, a person that is not the patient in which the biologicmaterial is to be implanted, or other animals.

Additional disclosures pertaining to synthetic or polymer materials andbiologic materials that can be used in conjunction with the disclosuresprovided herein can be found in U.S. Patent Application Publication No.2012/0080335, U.S. Patent Application Publication No. 2012/0083835, U.S.patent application Ser. No. 13/433,115, entitled “Tissue ThicknessCompensator Comprising Capsules Defining a Low Pressure Environment,”and filed on Mar. 28, 2012, U.S. patent application Ser. No. 13/433,118,entitled “Tissue Thickness Compensator Comprised of a Plurality ofMaterials,” and filed on Mar. 28, 2012, U.S. patent application Ser. No.13/532,825, entitled “Tissue Thickness Compensator Having ImprovedVisibility,” and filed on Jun. 26, 2012, U.S. patent application Ser.No. 13/710,931, entitled “Electrosurgical End Effector with TissueTacking Features,” and filed on Dec. 11, 2012, and U.S. patentapplication Ser. No. 13/763,192, entitled “Multiple ThicknessImplantable Layers for Surgical Stapling Devices,” and filed on Feb. 8,2013, each of which is incorporated by reference herein in its entirety.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one of a component of the end effectorand the staple cartridge prior to firing the device. The adjunctmaterial may be refrigerated, and thus removed from the refrigerator andthe related packaging, and then coupled to the device using a connectionor retention member as described herein or otherwise known to thoseskilled in the art. The stapling procedure can then be carried out asknown to those skilled in the art, and if necessary, the adjunctmaterial can be disassociated with the device as described above.

Retention Members

Connection or retention members can be used to secure, at leasttemporarily, one or more pieces of adjunct material onto an end effectorand/or staple cartridge. These retention members can come in a varietyof forms and configurations, such as one or more sutures, adhesivematerials, staples, brackets, snap-on or other coupling or matingelements, etc. For example, the retention members can be positionedproximate to one or more sides and/or ends of the adjunct material,which can help prevent the adjunct material from peeling away from thestaple cartridge and/or the anvil face when the end effector is insertedthrough a trocar or engaged with tissue. In still other embodiments, theretention members can be used with or in the form of an adhesivesuitable to releasably retain the adjunct material to the end effector,such as cyanoacrylate. In at least one embodiment, the adhesive can beapplied to the retention members prior to the retention members beingengaged with the adjunct material, staple cartridge, and/or anvilportion. Generally, once firing is completed, the retention member(s)can be detached from the adjunct material and/or the end effector sothat the adjunct material can stay at the surgical site when the endeffector is removed. Some exemplary, non-limiting embodiments ofretention members are described herein with respect to FIGS. 12-15.

FIG. 12 illustrates one exemplary embodiment of a connection orretention member 202 associated with the adjunct material 200 to securethe material 200 at a temporary location with respect to the lower jaw52 of the end effector 50. As shown, the adjunct material 200 isdisposed over the staple cartridge 100 located in the elongate channel56 of the lower jaw 52, and the retention member 202 extendstherethrough. In the embodiment, the retention member 202 is in the formof a single suture stitched through multiple locations of the adjunctmaterial 200, or it can be multiple sutures disposed at one or morelocations on the adjunct material 200. As shown, the sutures arepositioned at locations around a perimeter of the adjunct material 200,and are also adjacent to a central longitudinal channel 201 formed inthe adjunct material 200. The channel 201 can make it easier for a knifepassing through the adjunct material 200 to cut the material 200 intotwo or more separate strips. In some embodiments, for instance when theretention member 202 is a single suture threaded through multiplelocations of the adjunct material 200, a knife passing through the lowerjaw 52 can cut the retention member 202 at one or more locations,thereby allowing the retention member 202 to be disassociated from theadjunct material 200 and removed from the surgical site while theadjunct material 200 remains held at the surgical site by one or morestaples ejected from the cartridge 100.

FIG. 13 illustrates another embodiment of a connection or retentionmember 202′ associated with the adjunct material 200′ to secure thematerial 200′ at a temporary location on the end effector 50. Theretention member 202′ has the same configuration as the retention member202 in FIG. 12, however, in this embodiment it is used to secure thematerial to the anvil or upper jaw 54, rather than the cartridge orlower jaw 52.

FIG. 14 illustrates another, non-limiting embodiment of a connection orretention member 202″ used to releasably retain an adjunct material 200″to at least one of the upper jaw 54 and the lower jaw 52. In thisembodiment, the retention member 202″ is a single suture that extendsthrough a distal portion 200 d″ of the adjunct material 200″ and iscoupled to a proximal end 54 p of the upper jaw 54. Terminal ends 202 t″of the retention member 202″ can be used to move the retention member202″ with respect to the jaws 54, 52. In its extended position, which isillustrated in FIG. 14, the retention member 202″ can hold the adjunctmaterial 200″ in position as the end effector 50 is inserted into asurgical site. Thereafter, the jaws 52, 54 of the end effector 50 can beclosed onto tissue, for example, and staples from the staple cartridge100 can be deployed through the adjunct material 200″ and into thetissue. The retention member 202″ can be moved into its retractedposition such that the retention member 202″ can be operably disengagedfrom the adjunct material 200″. Alternatively, the retention member 202″can be retracted prior to the staples being deployed. In any event, as aresult of the above, the end effector 50 can be opened and withdrawnfrom the surgical site leaving behind the adjunct material 200″ andtissue.

FIG. 15 illustrates yet another, non-limiting embodiment of a connectionor retention member 202′″ for securing a location of adjunct material200′″ to an end effector. In particular, the adjunct material 200′″ andretention member 202′″ are used in conjunction with the end effector 50′of FIGS. 9 and 10. In this embodiment, the retention member 202′″ is inthe form of a suture that is used to tie the adjunct material 200′″ tothe first, lower jaw 52′ at proximal and distal ends thereof 52 p′, 52d′. Similarly, as shown in FIGS. 9 and 10, the adjunct material 200′″can also be secured to the second, upper jaw 54′ at proximal and distalends thereof 54 p′, 54 d′. Optionally, recesses can be formed in eitheror both of the jaws 52′, 54′, and either or both of the adjunctmaterials 200′″, which can protect the retention members 202′″ againstunintended cutting by an outside object. In use, the knife blade 81′ onthe driver assembly 80′ can incise the retention members 202′″ as itpasses through the end effector 50′ to release the adjunct material200′″.

A person skilled in the art will recognize a variety of other ways bywhich the adjunct material can be temporarily retained with respect tothe end effector. In various embodiments a connection or retentionmember can be configured to be released from an end effector anddeployed along with a piece of adjunct material. In at least oneembodiment, head portions of retention members can be configured to beseparated from body portions of retention members such that the headportions can be deployed with the adjunct material while the bodyportions remain attached to the end effector. In other variousembodiments, the entirety of the retention members can remain engagedwith the end effector when the adjunct material is detached from the endeffector.

Hybrid Adjunct Materials with Compressible Elastic Members

The compressible elastic members described herein, or otherwise known tothose skilled in the art, can be used in conjunction with a variety ofadjunct materials. While in some instances adjunct materials can beeither a synthetic material or a biologic material, in variousembodiments the adjunct material includes both synthetic material(s) andbiologic material(s) (i.e., it is a hybrid adjunct material). Theresulting combination can advantageously exhibit beneficial featuresfrom both types of materials in a single hybrid material. For example, ahybrid adjunct material can be designed to combine benefits of biologicmaterial (such as improved healing and tissue growth at a surgical site)with desirable mechanical properties of synthetic material (such asspringiness or elasticity). In various embodiments, a synthetic materialcan also provide structure and support for a biologic material (e.g.,add strength and/or shear resistance to fibrous biologic material),while still allowing the biologic material to contact a surgical siteand support and/or promote healing. Further, hybrid adjunct materialscan be configured to help reduce inflammation, promote cell growth,and/or otherwise improve healing. The hybrid adjunct material can bebioimplantable and bioabsorbable.

FIG. 16 is a perspective view of an exemplary staple cartridge assemblythat includes a cartridge body and a hybrid adjunct material. Here, thecartridge body and staples (not shown) are encased by lower jaw 1052 ofan end effector of a surgical instrument (see, e.g., FIGS. 1 and 10).The cartridge body has a plurality of staple cavities configured to seatstaples therein (see, e.g., FIGS. 4 and 10). The hybrid adjunct material600 is releasably retained on the cartridge body and the lower jaw 1052and configured to be delivered to tissue by deployment of the staplesfrom the cartridge body (as will be discussed in connection with theexample of FIGS. 21-23 below). The material 600 includes a biologictissue membrane or matrix 604 (shown as being partially cutaway toillustrate the compressible elastic members or spring members 616), asynthetic substrate layer or matrix 602, and at least one compressibleelastic member or spring member 616 configured to compress when acompressive force is applied thereto, and to provide a spring back forcewhen the compressive force is removed. Because the compressible elasticmember or spring member 616 (also referred to as a “skeleton”) isinternal to the biologic tissue membrane or matrix 604, irritation andinflammation from synthetic material can be minimized while the biologictissue membrane or matrix 604 is still provided with a compliantreinforcement.

In the illustrated embodiment of FIG. 16 (and similarly in FIGS. 17-19and 21-23), the biologic tissue membrane 604 is on a tissue contactingside of the hybrid adjunct material 600 while the synthetic substratelayer 602 is on the side of the material 600 facing the cartridge body.A person skilled in the art will also appreciate that the relativepositions of layers 602 and 604 can be reversed. A person skilled in theart will also appreciate that while the cartridge assembly of FIG. 16includes a hybrid adjunct material, an adjunct material that includesone or more spring members and only one of a biologic layer and asynthetic layer may alternatively be used. In various embodiments,hybrid adjunct materials can include a number (and arrangement) ofcompressible spring members selected to achieve a desired mechanicalproperty. For example, the number of spring members may be matched tothe number (and location) of staples, or the number of spring membersmay be the number required to cover the biologic tissue membrane orsynthetic substrate layer, or a predetermined region thereof (e.g., afunction of the size of the spring member and membrane or layer).

Further, in the illustrated embodiment of FIG. 16 (and similarly inFIGS. 17-19 and 21-23), the hybrid adjunct material is assembled to anend effector for context and ease of description. A person skilled inthe art will appreciate that that hybrid adjunct materials can beprovided in alternatively configured assemblies with an end effector,and can be provided separately from an end effector (or other componentof a surgical stapler) and subsequently affixed to a portion of the endeffector.

The hybrid adjunct material can be coupled to a jaw of the end effector(in this example through the synthetic substrate layer) and can includeone or more mating features for receiving and coupling to a biologiclayer. For example, FIG. 16 illustrates a synthetic material, layer, ormatrix 602 of the hybrid adjunct material 600 coupled to the jaw 1052using retention members 1202 extending across proximal and distal ends1052 p, 1052 d thereof. Further, the synthetic matrix 602 can includeone or more protrusions, shown here as springs 616, which are configuredto engage a biologic material, layer, or matrix 604 to assist in matingthe biologic matrix 604 to the synthetic matrix 602, therebysubstantially maintaining a location of the biologic matrix 604 withrespect to the synthetic matrix 602.

In this embodiment, the compressible elastic members or spring members616 form a skeletal structure around which the biologic matrix 604 isformed. For example, when the biologic matrix 604 is formed fromcollagen, which as discussed elsewhere in this disclosure can be meltedinto a liquid state and then reformed into a hardened state, thesynthetic matrix can be dipped in liquid collagen. As the collagenreforms or hardens, it can form around the skeletal structure defined bythe configuration of the springs 616, thereby integrating the biologicmatrix with the synthetic matrix. The resulting hybrid adjunct materialcan be a macro-composite adjunct that benefits from the strength andtear resistance of the internal synthetic frame and the simple parameterattachment features provided by the springs 616, e.g., the shape andmaterial of the springs, while still providing for the benefits ofhaving biologic material. A person skilled in the art will recognize avariety of other protrusions that can extend from a top surface 602 a ofthe synthetic matrix 602, to provide an internal skeletal structure forforming a hybrid adjunct material.

A person skilled in the art will appreciate that compressible elasticmembers having a variety of shapes, sizes, and configurations, andmaterials, can be used with the adjunct material disclosed herein. Inone embodiment, shown in FIG. 16, the adjunct material includes springmembers 616 in the form of elongate members that extend along at leastone dimension of the adjunct material. For example, in the illustratedembodiment, spring members 616 can be elongate members that have raisedsegments 618 separated by non-raised segments 617. In one example, theelongate members 616 can form a sinusoidal or wave-like pattern.Although FIG. 16 illustrates elongate members 616 extending across awidth (W) dimension, a person skilled in the act will recognize that theelongate members can alternatively, or in addition, extend along alength (L) dimension or another dimension (i.e., in FIG. 16, a dimensionthat is not parallel or perpendicular to the length dimension or widthdimension). A person skilled in the art will also appreciate that springmembers can take a variety of alternative forms. Virtually any shape canbe utilized as long as it is able to provide a spring back force when acompressive force is removed. Further, the spring member can be disposedin or on either the biologic and/or synthetic layer, or disposed betweenlayers.

FIGS. 17-20C illustrate additional exemplary attachments of biologicaltissue reinforcement membranes to cartridge bodies, and exemplarycompressible elastic members. In FIG. 17, the hybrid adjunct material2000 includes spherical, or orbit-like, elastic members 2016 disposedbetween a synthetic layer 2002 and biologic matrix 2004, and embeddedwithin the biologic matrix 2004. In FIG. 18, the hybrid adjunct material2100 includes radially projecting, atom-like, or jack-like elasticmembers 2116 embedded within the biologic matrix 2104. In FIG. 19, thehybrid adjunct material 2200 includes hemispherical, or domed, elasticmembers 2216 embedded within the biologic matrix 2204.

FIG. 20A is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 17. The spherical, or orbit-like, elasticmember 2320 includes a plurality of circular, or elliptical components2330 defining a three dimensional spherical, or orbit-like shape. Aperson skilled in the art will appreciate that such elastic members caninclude two or more circular or elliptical components, which can bearranged in a regular or irregular pattern. A person skilled in the artwill also appreciate that the mechanical properties of such elasticmembers can be modulated, for example, by appropriate selection of thematerial, size, shape, position, and/or number of circular or ellipticalcomponents. These and other elastic members can include one or moresurface features, or features of the three dimensional shape of theelastic member itself, configured to fix the membrane to the elasticmember. In the example of FIG. 20A, a membrane or matrix can extendaround a spherical, or orbit-like, elastic member 2320 and through theinterstices defined by the plurality of circular, or ellipticalcomponents 2330, thereby embedding and fixing the elastic member 2320 toand/or within the membrane or matrix.

FIG. 20B is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 19. The hemispherical, or domed elasticmember 2322 includes a plurality of curvilinear components 2332 affixedto a circular, or elliptical base 2342 and defining a three dimensionalhemispherical, or domed shape. A person skilled in the art willappreciate that such elastic members can include two or more curvilinearcomponents, which can be arranged in a regular or irregular pattern,fixed to a circular, elliptical, polygonal, or other two dimensionalbase. A person skilled in the art will also appreciate that themechanical properties of such elastic members can be modulated, forexample, by appropriate selection of the material, size, shape,position, and/or number of curvilinear components and base. These andother elastic members can include one or more surface features, orfeatures of the three dimensional shape of the elastic member itself,configured to fix the membrane to the elastic member. In the example ofFIG. 20A, a membrane or matrix can extend around a curvilinear elasticmember 2332 and through the interstices defined by the plurality ofcurvilinear elastic members 2332 and/or base 2342, thereby embedding andfixing the elastic member 2322 to and/or within the membrane or matrix.

FIG. 20C is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 18. The radially projecting, atom-like, orjack-like elastic members 2321 includes a nucleus 2331 from which arms2341 radiate and terminate in ball shaped end cap 2351. A person skilledin the art will appreciate that similar elastic members can include twoor more arms, which are not necessarily straight or equal in length,radiating from a nucleus, which is not necessarily the geometric centerof the elastic member. A person skilled in the art will also appreciatethat the mechanical properties of such elastic members can be modulated,for example, by appropriate selection of the material, size, shape,position, and/or number of arms, end caps, and other features. These andother elastic members can include one or more surface featuresconfigured to fix the membrane to the elastic member (e.g., ball shapedend caps, shelves, barbs, and the like). Features such as ball shapedend caps may have addition advantageous features, such as blunting thetip of arm 2341, thereby preventing the arm from piercing or otherwisedisrupting an adjacent region of membrane or matrix. In the non-limitingexample of FIG. 20C, the elastic member 2321 has radially projectingarms 2341 and ball shaped end caps 2351 can be embedded in a membrane ormatrix, thereby fixing the elastic member within the membrane or matrixand mitigating movement of the elastic member within the membrane ormatrix. A person skilled in the art will appreciate that other surfacefeatures and configurations can be used in other embodiments.

A person skilled in the art will appreciate that shapes other than thoseillustrated in the examples of FIGS. 17-20C, e.g., spheroid, ovoid,three-dimensional radial, non-symmetrical form, and functionally similartwo or three-dimensional elastic member shapes, can be used inalternative embodiments. Likewise, the elastic member need notnecessarily assume a configuration of the illustrated embodiments (e.g.,disposed between a synthetic layer and a biologic layer and/or embeddedwithin a biologic layer—the spring member can be disposed in or oneither the biologic and/or synthetic layer, or disposed betweenlayers.). A person skilled in the art will also appreciate that themechanical properties (e.g., compression and spring back behavior) of ahybrid adjunct material can be modulated by appropriate selection of thenumber, type, and/or arrangement of elastic members. For example, thetype and/or arrangement of elastic members can be uniform (e.g., similarto FIG. 17), random (e.g., similar to FIG. 18), or patterned (e.g.,similar to FIG. 19, to concentrate compression and spring back aroundthe staples). Furthermore, in various embodiments, a hybrid adjunctmaterial can include two or more different types of elastic membersand/or two or more patterns (e.g., regular pattern of a first type ofelastic member at staple sites and a random pattern of a second type ofelastic member elsewhere).

Elastic members can be made from essentially any synthetic materialhaving the desired mechanical (e.g., springiness, recoverableviscoelasticity, reinforcement and the like) and biologic (e.g.,bioimplantable and bioabsorbable) properties. Representative examplesare discussed in the IMPLANTABLE MATERIALS section above. Likewise,essentially any shape and configuration having spring-like propertiescan be used, assuming compatibility (e.g., shape, volume) with thehybrid adjunct material 600. A person skilled in the art will appreciatethat the shape of hybrid adjunct materials (and layers thereof) are notlimited to the parallelepiped/rhombohedron like forms shown in theillustrated examples. In various embodiments, hybrid adjunct materials(and layers thereof) are not necessarily symmetrical as shown in FIGS.16-19 and can, for example, vary in thickness or have irregularly shapedportions.

In another aspect, the invention provides a method for staplingbiological tissue. FIGS. 21-23 illustrate an example of one such method,through operation of the exemplary staple cartridge encased by lower jaw1052 of an end effector shown in FIG. 16. While the example method isdiscussed with reference to FIG. 16, it is understood that this andother methods provided by the present invention are applicable to theuse of adjunct materials with different types of spring membersdiscussed herein.

FIG. 21 illustrates the engagement of tissue 3000 with a surgicalstapler cartridge body 1100 at a surgical site. The cartridge body 1100has a hybrid adjunct material 600 releasably attached thereto. Thematerial 600 comprises a biologic tissue membrane 604, a syntheticsubstrate layer 602, and at least one compressible elastic member 616configured to compress when a compressive force is applied thereto, andto provide a spring back force when the compressive force is removed.Here, the tissue 3000 is engaged between an anvil or upper jaw 1054 andthe lower jaw 1052, which encases the cartridge body 1100 having staples1101 disposed therein, and which supports the hybrid adjunct material600.

FIG. 22 illustrates an actuated surgical stapler that has ejectedstaples 1101 from the cartridge body 1100, and into the biologicaltissue 3000. The staples 1101 extend through the hybrid adjunct material600 to maintain the material 600 at the surgical site. In this example,actuation of the surgical stapler also cuts the tissue 3000 at asurgical site between the staples 1101, as shown in FIG. 22. Furtherembodiments and examples of such cutting embodiments are describedabove. However, the present invention also contemplates embodimentswhere tissue is not necessarily cut, or where tissue is not necessarilycut concurrently with actuation of the surgical stapler.

FIG. 23 illustrates the tissue 3000 following deployment of staples 1101and adjunct material 600. As shown, the staples 1101 extend through thehybrid adjunct material 600 and the tissue 3000 to maintain the material600 at the surgical site. In this illustration, the tissue 3000comprising the staples 1101 is reinforced by the hybrid adjunct material600, thereby preventing or mitigating tearing, fluid (e.g., blood), orother undesired damage to the surgical site. Avoiding undesired damagecan decease surgical recovery time and mitigate surgical complications.Furthermore, the reinforcement can promote healing through the action ofthe biologic matrix 604 and/or biologically active compounds therein.Similarly, the reinforcement can prevent or mitigate irritation andinflammation from synthetic material because the elastic member orspring 616 is internal to the biologic tissue membrane or matrix 604and/or because the synthetic substrate layer 602 essentially does notcontact the tissue 3000. In alternative embodiments, essentially allsynthetic material can be encapsulated by biologic material, to preventor mitigate irritation and inflammation from synthetic material.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination,e.g., electrodes, a battery or other power source, an externallywearable sensor and/or housing thereof, etc. Upon cleaning and/orreplacement of particular parts, the device can be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device can utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

In some embodiments, devices described herein can be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Additional exemplary structures and components are described in U.S.application Ser. No. ______ [100873-639/END7352USNP] entitled “SealingMaterials For Use In Surgical Stapling”, Ser. No. ______[100873-640/END7353USNP] entitled “Hybrid Adjunct Materials For Use InSurgical Stapling”, Ser. No. ______ [100873-641/END7353USNP] entitled“Positively Charged Implantable Materials and Methods of Forming theSame”, and Ser. No. ______ [100873-642/END7355USNP] entitled “TissueIngrowth Materials And Method Of Using The Same”, which are filed oneven date herewith and herein incorporated by reference in theirentirety.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A staple cartridge assembly for use with asurgical stapler, comprising: a cartridge body having a plurality ofstaple cavities configured to seat staples therein; and a hybrid adjunctmaterial releasably retained on the cartridge body and configured to bedelivered to tissue by deployment of the staples in the cartridge body,the material having a biologic tissue membrane, a synthetic substratelayer, and at least one compressible elastic member configured tocompress when a compressive force is applied thereto, and to provide aspring back force when the compressive force is removed.
 2. The assemblyof claim 1, wherein the material is bioimplantable and bioabsorbable. 3.The assembly of claim 1, wherein the elastic member is disposed betweenthe biologic tissue membrane and the synthetic substrate layer.
 4. Theassembly of claim 1, wherein the elastic member is disposed in one orboth of the biologic and synthetic layer.
 5. The assembly of claim 1,further comprising at least one suture retention member configured tocouple the material to the cartridge body.
 6. The assembly of claim 5,wherein the at least one suture retention member is coupled to an outeredge of the cartridge body and an outer edge of at least one of thebiologic tissue membrane and the synthetic substrate layer.
 7. Theassembly of claim 6, wherein the at least one suture retention membercomprises a suture.
 8. The assembly of claim 1, wherein the membranecomprises a biological matrix.
 9. The assembly of claim 1, wherein thecompressible elastic member comprises a synthetic bioabsorbablematerial.
 10. The assembly of claim 9, wherein the syntheticbioabsorbable material comprises a nylon, polypropylene, polydioxanon, apolyglycerol sebacate (PGS), PGA (polyglycolic acid), PCL(polycaprolactone), PLA or PLLA (polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25), polyglactin910, polyglyconate, PGA/TMC (polyglycolide-trimethylene), polyhydroxybutyrate(PHB), poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), or acombination thereof.
 11. The assembly of claim 9, wherein thecompressible elastic member comprises at least one member extendingacross at least one dimension of the material in a sinusoidal pattern.12. The assembly of claim 11, further comprising a plurality ofsinusoidal members extending across at least one of a length dimensionand a width dimension of the material.
 13. The assembly of claim 9,wherein the compressible elastic member includes one or more surfacefeatures configured to fix the membrane to the elastic member.
 14. Theassembly of claim 13, wherein the one or more surface features areselected from the group consisting of ball shaped end caps, shelves,barbs, and combinations thereof.
 15. The assembly of claim 9, whereinthe compressible elastic member comprises one or more of a spheroid,ovoid, hemispherical, dome, jack-like, or three-dimensional radial form.16. A hybrid adjunct material, comprising: a biologic tissue membrane, asynthetic substrate layer, and at least one compressible elastic memberconfigured to compress when a compressive force is applied thereto, andto provide a spring back force when the compressive force is removed,wherein the material is configured to be releasably attached to asurgical stapler cartridge body for delivery to tissue upon deploymentof staples from the cartridge body.
 17. The hybrid adjunct material ofclaim 16, wherein the elastic member is disposed between the biologictissue membrane and the synthetic substrate layer.
 18. The hybridadjunct material of claim 16, wherein the elastic member is disposed inone or both of the biologic and synthetic layer.
 19. A method forstapling biological tissue, comprising: engaging tissue with a surgicalstapler cartridge body at a surgical site, the cartridge body having ahybrid adjunct material releasably retained thereon, the materialcomprising a biologic tissue membrane, a synthetic substrate layer, andat least one compressible elastic member configured to compress when acompressive force is applied thereto, and to provide a spring back forcewhen the compressive force is removed; and actuating the surgicalstapler to eject staples from the cartridge body into the biologicaltissue, the staples extending through the material to maintain thematerial at the surgical site.